The Total Neoadjuvant Therapy for Soft Tissue Sarcoma of the Extremities

Phase 2

Recruiting

• Conditions: Soft Tissue Sarcomas
• Interventions: Radiation: Hypofractionated Radiotherapy; Drug: 3 cycles of AI

• Registration Number: NCT06593899
• Lead Sponsor: Fujian Medical University Union Hospital

Brief Summary

For localized soft tissue sarcomas (STS) of the extremities, limb-sparing or conservative surgery with perioperative radiotherapy (RT) is the standard of care. However, several challenges persist. Notably, there are exceedingly high rates of distant metastatic recurrence even after surgical resection and RT, and conventional fractionated radiotherapy has a prolonged duration (5-6 weeks). With advancements in RT technology, the gradual expansion of hypofractionated radiotherapy regimens enables significantly shorter treatment durations. Promising recent reports on 1-week hypofractionated RT regimens, such as the 5X5 Gy RT regimens, have demonstrated reasonable local control and acceptable toxicity in resectable STS.Addressing the challenge of distant metastasis, previous studies have indicated that AI regimens are expected to eliminate micrometastases and improve survival in patients with STS at a high risk of distant relapse. Therefore, the goal of this clinical trial is to investigate whether hypofractionated RT combined with a sequential chemotherapy（AI regimens）can enhance short-term treatment efficacy for extremity STS patients without compromising local control rates and increasing related toxicities

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study Start: 2024-05-01
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13
• Primary Completion: 2025-12-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

1. Primary soft tissue sarcoma of the extremities, with one of the following characteristics: high grade, ≥5cm or deep tumor, the need for neoadjuvant radiotherapy was determined after multidisciplinary consultation.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
3. Age 18-75 years old.
4. Histologic diagnosis of soft tissue sarcoma.
5. Can tolerate radiotherapy and AI regimen treatment.
6. The function of major organs is normal.

Exclusion Criteria

1. There were no patients with gross tumors after unplanned mass resection in another hospital.
2. Patients with other comorbidities cannot use AI chemotherapy: drug allergy, active bleeding, ulcers, intestinal perforation, intestinal obstruction, uncontrollable hypertension, grade III-IV cardiac insufficiency (NYHA standards), severe liver and renal insufficiency ( Level IV) etc.
3. New malignant tumors within 5 years (except cervical carcinoma in situ or early cutaneous basal cell carcinoma).
4. Pathological types: nonpleomorphic rhabdomyosarcoma, Ewing sarcoma.
5. Soft tissue sarcoma curable by simple expansion.
6. Previous history of radiotherapy to the same site.
7. Combined with distant metastasis (M1) or lymph node metastasis (N1).
8. Have other severe medical comorbidities that preclude surgery or participation in the study.
9. Previous exposure to chemotherapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypofractionated Radiotherapy	Hypofractionated Radiotherapy	The patients in the study underwent a 1-week course of hypofractionated radiotherapy. Following the completion of radiotherapy, chemotherapy with the AI regimen (doxorubicin + ifosfamide) was initiated one week later. The AI regimen chemotherapy was administered for a duration of 9 weeks. Subsequently, surgery was scheduled to commence 1-2 weeks after the completion of chemotherapy.
Hypofractionated Radiotherapy	3 cycles of AI	The patients in the study underwent a 1-week course of hypofractionated radiotherapy. Following the completion of radiotherapy, chemotherapy with the AI regimen (doxorubicin + ifosfamide) was initiated one week later. The AI regimen chemotherapy was administered for a duration of 9 weeks. Subsequently, surgery was scheduled to commence 1-2 weeks after the completion of chemotherapy.

Primary Outcome Measures

Name	Time	Method
The proportion of EORTC-STBSG classifications A-C (less than 10% tumour residual)	Surgery

Secondary Outcome Measures

Name	Time	Method
Postoperative wound complications	3 months
Overall survival	24 months after treatment completion
Local control	24 months after treatment completion

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China